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NOT YET RECRUITING
NCT07609654
PHASE4

Oral Anticoagulation After Stroke With Prior ICH in Subjects With AF

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

Summary

This prospective, multicenter, randomized controlled trial aims to evaluate the efficacy and safety of initiating direct oral anticoagulants (DOACs) in patients with a history of spontaneous intracerebral hemorrhage (ICH) and non-valvular atrial fibrillation (AF) who have recently suffered an acute ischemic stroke. Existing evidence regarding the optimal antithrombotic strategy for this specific high-risk "double-jeopardy" population remains largely undefined. Eligible participants will be randomized in a 1:1 ratio to either receive oral anticoagulation therapy or a non-anticoagulation standard of care. The primary objective is to assess the incidence of a composite endpoint consisting of recurrent ischemic stroke and recurrent ICH over a 12-month follow-up period.

Official title: A Prospective, Multicenter, Randomized Controlled Trial of Anticoagulation Therapy After Ischemic Stroke in Patients With Previous Intracerebral Hemorrhage and Atrial Fibrillation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

852

Start Date

2026-06-01

Completion Date

2029-09-01

Last Updated

2026-05-27

Healthy Volunteers

No

Interventions

DRUG

Direct Oral Anticoagulants (DOACs)

Administration of approved DOACs (e.g., apixaban, rivaroxaban, edoxaban, or dabigatran) at standard stroke prevention dosages.

DRUG

Antiplatelet Therapy or No Antithrombotic Therapy

Administration of single antiplatelet agents or avoidance of antithrombotic therapy, representing the current variable standard of care.